Real-World Observation of the EkoSonic Endovascular System in Chinese Adults with Acute Pulmonary Embolism

What this Trial Is About

This research aims to gather real-world data on the clinical outcomes of the EkoSonicTM Endovascular System in Chinese adults diagnosed with acute pulmonary embolism. The study focuses on patients who have symptoms lasting less than 14 days and a specific heart measurement indicating right ventricular strain. This observational study will include up to 30 participants receiving this treatment during their standard clinical care. Participants will be treated with the EkoSonicTM Endovascular System, which is a non-implanted device consisting of a single-use infusion catheter with an ultrasonic core and a reusable control system. The device is used alongside a medication called r-tPA to treat the pulmonary embolism. The study observes these treatments as they are given in routine care without randomization or comparison groups. During the study, participants will have various assessments including echocardiographic measurements of the right and left ventricles at baseline, 24 and 48 hours after treatment, at discharge, and during follow-ups at 1, 3, and 6 months, continuing on average for one year. Researchers will also monitor pulmonary embolism events and serious adverse events related to the device or procedure. Participants will be followed for safety and efficacy outcomes throughout the study period.

A Real-World Study of EkoSonic Endovascular System in Chinese Populations With Acute Pulmonary Embolism